title: Validity and reliability of a novel slow cuff-deflation system for noninvasive blood pressure monitoring in patients with continuous-flow left ventricular assist device.
abstract: BACKGROUND
  Doppler ultrasound is the clinical gold standard for noninvasive blood pressure (BP) measurement among continuous-flow left ventricular assist device patients. The relationship of Doppler BP to systolic BP (SBP) and mean arterial pressure (MAP) is uncertain and Doppler measurements require a clinic visit. We studied the relationship between Doppler BP and both arterial-line (A-line) SBP and MAP. Validity and reliability of the Terumo Elemano BP Monitor, a novel slow cuff-deflation device that could potentially be used by patients at home, were assessed.
  
  
  RESULTS
  Doppler and Terumo BP measurements were made in triplicate among 60 axial continuous-flow left ventricular assist device (HeartMate II) patients (30 inpatients and 30 outpatients) at 2 separate exams (360 possible measurements). A-line measures were also obtained among inpatients. Mean absolute differences (MADs) and correlations were used to determine within-device reliability (comparison of second and third BP measures) and between-device validity. Bland-Altman plots assessed BP agreement between A-line, Doppler BP, and Terumo Elemano. Success rates for Doppler and Terumo Elemano were 100% and 91%. Terumo Elemano MAD for repeat SBP and MAP were 4.6±0.6 and 4.2±0.6 mm Hg; repeat Doppler BP MAD was 2.9±0.2 mm Hg. Mean Doppler BP was lower than A-line SBP by 4.1 (MAD=6.4±1.4) mm Hg and higher than MAP by 9.5 (MAD=11.0±1.2) mm Hg; Terumo Elemano underestimated A-line SBP by 0.3 (MAD=5.6±0.9) mm Hg and MAP by 1.7 (MAD=6.0±1.0) mm Hg.
  
  
  CONCLUSIONS
  Doppler BP more closely approximates SBP than MAP. Terumo Elemano was successful, reliable, and valid when compared with A-line and Doppler.
authors.affiliation: New York Presbyterian, Columbia University, New York, NY.
authors.forename: Gregg M
authors.initials: GM
authors.lastname: Lanier
authors.forename: Khristine
authors.initials: K
authors.lastname: Orlanes
authors.forename: Yacki
authors.initials: Y
authors.lastname: Hayashi
authors.forename: Jennifer
authors.initials: J
authors.lastname: Murphy
authors.forename: Margaret
authors.initials: M
authors.lastname: Flannery
authors.forename: Rosie
authors.initials: R
authors.lastname: Te-Frey
authors.forename: Nir
authors.initials: N
authors.lastname: Uriel
authors.forename: Melana
authors.initials: M
authors.lastname: Yuzefpolskaya
authors.forename: Donna M
authors.initials: DM
authors.lastname: Mancini
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Naka
authors.forename: Hiroo
authors.initials: H
authors.lastname: Takayama
authors.forename: Ulrich P
authors.initials: UP
authors.lastname: Jorde
authors.forename: Ryan T
authors.initials: RT
authors.lastname: Demmer
authors.forename: Paolo C
authors.initials: PC
authors.lastname: Colombo
mesh_terms: D000368:Aged; D000704:Analysis of Variance; D062186:Arterial Pressure; D001795:Blood Pressure Determination / Q000295:instrumentation*; D003971:Diastole; D004867:Equipment Design; D005260:Female; D006333:Heart Failure / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D006353:Heart-Assist Devices; D006801:Humans; D016014:Linear Models; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D011237:Predictive Value of Tests; D011446:Prospective Studies; D015203:Reproducibility of Results; D019722:Sphygmomanometers; D013599:Systole; D013997:Time Factors; D016896:Treatment Outcome; D018608:Ultrasonography, Doppler
keywords: Terumo Elemano; blood pressure measurement/monitoring; heart failure; heart-assist devices